Senior CRA, FSP

• Contribute to the selection of potential investigators
• Support study start-up and regulatory maintenance, including site qualification visits and EC/IRB and regulatory authority submissions where required
• Train, support, and advise investigators and site staff on study-related matters, including Risk Based Quality Management principles
• Confirm required site-staff training completion and maintain inspection readiness
• Participate in Local Study Team meetings and National Investigators meetings as applicable
• Initiate, monitor, and close study sites in compliance with applicable procedures
• Share patient recruitment and site quality/performance information with the Local Study Team
• Drive site performance, resolve study-related issues, and escalate issues appropriately
• Update CTMS and other systems with site data within required timelines
• Manage study supplies, drug supplies, and drug accountability; prepare study drug for destruction where applicable
• Perform remote and onsite monitoring visits and remote data checks according to the study Monitoring Plan
• Perform Source Data Review, Case Report Form review, and Source Data Verification
• Conduct Site Quality Risk Assessments and adapt monitoring intensity during the study
• Ensure timely data-query resolution and collaborate with data management on study-data quality
• Ensure accurate and timely reporting and follow-up of Serious Adverse Events
• Prepare and finalize monitoring visit reports in CTMS and provide timely feedback to Principal Investigators
• Follow up on outstanding site actions
• Escalate systematic or serious quality issues, data privacy breaches, CSP or ICH-GCP compliance issues
• Assist sites in maintaining inspection-ready Investigator Site Files
• Prepare for and collaborate on audits and regulatory inspections
• Ensure timely collection and uploading of essential documents into the eTMF and support quality-control checks
• Ensure study documents are ready for final archiving and completion of the local eTMF
• Provide research-related market feedback on sites, investigators, and competing studies
• Ensure compliance with AstraZeneca’s Code of Ethics, policies, procedures, and applicable legislation
• Collaborate with local MSLs as directed

• Minimum 3–5 years' experience as a monitor
• Ability to work independently and monitor all stages of a study across different phases
• Special therapeutic expertise in oncology
• Ability to take on LST tasks and support the LST with coordination or document preparation as required
• Ability to travel internationally as required
• Valid driving license
• ICH-GCP knowledge and compliance
• Ability to work in compliance with AZ Procedural Documents and relevant local regulations
• Ability to complete monitoring, source data review, CRF review, and source data verification activities
• Ability to manage study-site documentation, supplies, drug accountability, and essential documents
• Ability to use CTMS and other study systems
• Ability to ensure timely resolution of data queries and serious adverse event reporting
• Ability to support audits, regulatory inspections, quality processes, and inspection readiness

• Fully remote work mode
• Standard Monday–Friday work schedule